Female luer connector disinfecting cap

ABSTRACT

A cleaning device for a medical implement such as a female Luer connector. The cleaning device includes a cap having an interior cavity and an opening adapted to receive a site of the medical implement. The interior cavity is defined by an interior wall that includes a male Luer protrusion extending in the direction of the opening from an end of the interior cavity opposite the opening. A skin of cleaning material overlies at least a portion of the interior wall. The cleaning material may be pre-loaded with a cleaning agent and is adapted to clean the site of the medical implement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/285,526, filed May 22, 2014, now pending, which is a divisional ofU.S. application Ser. No. 13/099,324, filed May 2, 2011, issued as U.S.Pat. No. 9,259,284, which claims priority to U.S. ProvisionalApplication No. 61/330,243, filed Apr. 30, 2010, the disclosures ofwhich are incorporated by reference in their entirety herein.

BACKGROUND

The present invention relates to cleaning devices, and more particularlyto a universal connector cap capable of cleansing a connector ofpathogens or other harmful materials or contaminants, for example byemploying a friction-based fitting to a connector site or other medicalimplement.

In the medical field, there is often a need to connect tubing to avariety of devices to facilitate the administration of fluids to apatient. To allow tubing and components from different manufacturers ofa variety of devices to connect with one another, a standard connectortype was developed. The connector type generally consists of a maleconnector (or “port,” which is used interchangeably herein) beinginserted into a female connector whereby friction can keep themtogether. The taper of the male connector can be adapted to closelymatch the taper of the female connector to create a friction orcompression type connection that is fluid tight. For infusion oraspiration of fluids to or from an intravenous or arterial access lineor device, i.e. including, without limitation, a catheter, IV set,extension set stopcock, syringe, valve, etc., this type of connector isknown as a Luer fitting, a Luer connector, a Luer lock, or the like. Thedimensions of Luer connectors, which are referred to herein genericallyas a “Luer” or “Luers,” can be found in ISO Standards 594-1 and 594-2.

Luers were later improved with threading mechanisms to allow and assistthe two connectors to screw together, whereby friction was again theholding force. This threading was merely an enhancement to enable a userto more easily drive the male and female connectors together. If afemale port remains open when not connected, there is an increased riskof infections, leakage of fluid and other problems resulting from havingopen access to the patient. To eliminate this “open” problem, a rubberport can be used for the female connector that can keep the female portclosed until used for injections. The rubber port was typically piercedwith a needle, or can be removed to connect the female connector withother tubing.

The female connector was further improved with one of several otherfeatures, such as a split septum, biased septum, displaceable pistonetc. that can be displaced from a closed position by the male connectorwhen it needs to be out of the way, but which can spring back to theclosed position as required. This device was highly desirable because iteliminated the dangerous needle and its closure was automatic. Thisdevice is commonly called a needleless adapter, or a Luer ActivatedValve (LAV). For instance, the Luer tapered male port on standardsyringes can open a fluid path without a needle, through or around thedisplaced feature on the female side when the two were pressed orscrewed together. After the injection of fluids, the syringe wasunscrewed/removed. Upon removal, the needle-free feature (whether abiased plug/piston, split septum or other displaceable construct) is,without user interaction, automatically biased back into its normallyclosed position.

This improvement simplified the administration of fluids by removingneedles and reducing open port risks but still necessitated the use of adisinfecting wipe prior to insertion since the outside features of theconnection can still remain exposed to touch and air contamination.

SUMMARY

This document describes features of cleaning devices for medicalimplements as well as methods for using such devices. In one aspect, acleaning device includes a cap having an opening to an inner cavity. Theopening is adapted to receive a site of the medical implement. The innercavity includes a male Luer protrusion that extends up from an innerwall toward the opening, and is sized and adapted for insertion into afemale Luer when the cap is provided on the medical implement. Thecleaning device further includes a compressible cleaning material thatsurrounds the male Luer protrusion and that contains a cleaning agentprior to receipt of the site of the medical implement, i.e. the cleaningmaterial is pre-loaded with the cleaning agent. The compressiblecleaning material is at least partially secured in the inner cavity andadapted to swab and clean the site with the cleaning agent, includingcleaning the female Luer and inner lumen therein.

The cap can further include a friction-forming member for creating afriction-based fitting of the cap onto the site of the medicalimplement. Alternatively, the cap further includes a member, for exampleone protruding from threading at the opening of the inner cavity, that,once the cap is fitted onto the site of the medical implement, inhibitseasy removal of the cap until a force exerted on the cap exceeds acertain threshold of force. The cap can further include one or moreenergy directors on which a threaded ring is mated to a receptacle inthe cap. The cap can be filled with a cleaning material and cleaningsolution, such as a foam pad with an antibacterial or antimicrobialsolution. Alternatively, the cap can be filled with a gel, foam or waxthat includes an antibacterial or antimicrobial component.

The details of one or more embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings:

FIG. 1 shows a male cleaning device;

FIG. 2 shows a variation of a cleaning device;

FIG. 3 shows yet another variation of a cleaning device; and

FIG. 4 shows a process flow chart showing at least one featureconsistent with an implementation of the current subject matter.

When feasible, like reference symbols in the various drawings indicatelike elements.

DETAILED DESCRIPTION

An improved cleaning device has been created that acts as a combinationcap and disinfecting swab whereby it screws on or is otherwise fittedonto the closed female side of a Luer activated valves (i.e. LAV). Thecleaning device contains features to disinfect or sterilize the externalsurface of the closed female port, and further protects the surface fromfurther contamination as long as it remains fitted on to the femaleport. The cleaning device includes the male feature, i.e. the taperedcone or tapered cylinder, to open the female Luer valve as well as cleanthe outer and inner surfaces of the Luer valve around the septum. Lueractivated valves are typically made of very rigid plastics such aspolycarbonate or acrylic. The female connection of the Luer has threadsand a root diameter.

A cleaning device in the form of a cap to clean the female connectioncan be provided as exemplified in U.S. patent application Ser. No.11/705,805, filed Feb. 12, 2007, the contents of which are incorporatedherein by reference for all purposes. The cleaning device for a medicalimplement includes a cap having an opening to an inner cavity. An innersurface of the opening includes one or more threads adapted to receive asite of the medical implement. The cleaning device further includes acleaning material formed of a compressible material that is at leastpartially secured or supported in the inner cavity. The cleaningmaterial contains a cleaning agent that effectively eliminates pathogensand other harmful materials from the site and that can be activated fromthe cleaning material by twisting and fitting the cap onto the site,particularly if the cap is fitted onto the site for a period of time.

The one or more threads of the cleaning device can be provided by athreaded ring adapted to be fixedly positioned at the inner surface ofthe opening of the cap. Two threads encircle approximately one-quarterto one-half of the inner surface of the threaded ring. A tab extendsfrom each thread, preferably at the lower terminus of each thread. Thetab can be made thinner than the rest of the thread, to allow flexure orbending. The threaded ring can be formed by plastic injection molding.The threads are formed such that the threaded ring does not need to beunwound during molding or fabrication. The tabs of each thread engagewith the outer threading of a valve or port, and any gap providedthereby allows for compatibility with many sized valves or ports, aswell as allows limited evaporation of cleaning solution (such asisopropyl alcohol) that might be inside the cap.

The tabs create friction on one or both outer sides of the femaleconnection of the Luer, thereby preventing the cap from unscrewing fromthe female connection of the Luer. In some implementations, the threadsof the cap correspond to an ISO Luer Standard thread. Each tab pressesagainst the root diameter of the female Luer and presses on the sides ofthe thread feature of the female connection, thereby creating friction.The threading and one or more protrusions cooperate to create acompression fit and to prevent the cap from accidentally coming off thesite onto which it is fitted.

The threads of the cap, and/or the protrusions of added material, can bemade of a softer, more compressible material than the cap or the femaleconnector, such as another type of plastic or a rubber, etc. Thefeatures pressing on the female side can work in several ways. The addedmaterial can press against the more rigid female LAV root or body orthreads to create friction. The added material can also displace plasticto create a single use scenario, where the part pressing on the threadpushes against the outside of the thread or on the sides of the thread.The material can further deflect in a variety of ways to make putting onsimple, and taking off more difficult.

Additionally the cap can be configured for being pressed on instead of,or in addition to, being screwed on, with material that protrudes fromthe inner ring or threads of the cap to press against the threads orroots of the female connection of the LAV, similar in function to a starretaining washer. It can have simple features on the press parts thatcreate resistance when pulled off. The protruding “flaps” can bebendable to allow the cap to be forced over the female threads. Oncepast the threads or a section of threads, the “flaps” can naturallyreturn to their unbent state to prevent the inadvertent removal of thecap. To remove, it may be possible to unscrew the cap where the flapsfind the thread track, but the user can just pull off the cap uponexceeding a certain threshold force to overcome the resistance by theadded material and/or the threads of the cap.

FIG. 1 shows a cleaning device 100, including a cap portion 102 thatincludes a cap 104 with an opening 106 to an interior cavity 107. Thecap 104 can be formed of rigid plastic, such as high densitypolyethylene (HDPE) plastic. A removable foil lid 108 is adapted toclose the opening 106, and can be sealed on the top outer periphery ofthe opening 106 by a heat or thermal process. The opening 106 isslightly wider in diameter than the rest of the interior cavity 107 toform a ring receptacle 110 and to be able to receive a threaded ring 112as described above. The threaded ring 112 can be ultrasonically welded,glued, or otherwise attached into the receptacle 110. The ringreceptacle 110 includes a number of energy directors in the form ofbumps or protrusions that enable welding or bonding of the threaded ring112 into the ring receptacle 110. The energy directors also stabilizethe threaded ring 112 for proper alignment and mounting, and can resistagainst turning the threaded ring 112 relative to the cap 104 when thecleaning device 100 is screwed on or otherwise applied to a port orvalve.

The top interior wall 114 of the cap 104 includes a male luer protrusion116 extending up toward the opening 106 of the cap 104, preferablyformed as a portion of a tapered cone or cylinder. The male Luerprotrusion 116 is ringed by cleaning material 118 formed of acompressible material that is at least partially secured in the innercavity 107. The depth or height 120 of the cleaning material can bevaried, but in preferred implementations the compressible cleaningmaterial is at least the same or shorter height than height 122 of thetop of the male luer protrusion 116.

The top interior wall 114 of the cap 104 can have one or moreprotrusions 116 extending up from the interior wall 114 toward theopening 106 of the cap 104. The one or more protrusions 116 can be usedto support a cleaning material 118 such as foam, cotton, or other porousmaterial, or provide stability to a thixotropic cleaning solution as analternative. The cleaning material exists in the form of a doughnut. Insome implementations, the one or more protrusions 116 can be formed of aflexible material to contact and scrub the forward face of a valve orport, such as the septum of a valve.

The cleaning device 100 provides many advantages. For example, thecleaning device 100 can be easily manufactured. The cleaning device 100can be easily fit on appropriate devices, such as machines. Further, thecleaning device 100 can be manufactured such that the cleaning device100 fits any Luer thread. The cleaning device can use different toolsfor threading. When using a dialysis tube, an inner lumen of the hub,outside threads, and the face of hub can optionally also be disinfected.Cores can be redesigned using a custom tool to obtain new design caps.Length and wings can be added to obtain a new tool for the cap. The newtool can be a further enhancement to an existing tool.

FIG. 2 shows an alternative implementation 200 of a cleaning device,similar to the device 100 shown in FIG. 1, in which the male Luerprotrusion 202 is formed of a plug of a cleaning material (e.g. foam,cotton, or other porous material) 204 that is preloaded with a cleaningagent 206 such as isopropyl alcohol. The cleaning device 200 has a highconfidence level of reducing or eliminating infection. The plug 204 caninclude the protrusion 202 ringed by a channel 208, and can also includeside walls 210 surrounding the outside of the channel 208. The plug 204can be secured into the interior cavity 212 of the cap by posts 213, byadhesive, or by a series of barbs that extend up from the top interiorwall 214 of the cap 216. The posts 213 can be molded by a heat-stakingprocess. Any damage by heat staking can be prevented or minimized byusing suitable techniques.

FIG. 3 shows another implementation 300 of a cleaning device, combiningcertain features from the devices (100, 200) shown in FIGS. 1 and 2. Thecap 302 is similar to the caps 104, 216, but the male Luer protrusion304 can be integral with the cap material 305, i.e. formed of a singlemold. A molded “skin” of foam or some other cleaning material layer 308is overlaid on some or most of the surface of the interior cavity 310,including the male luer protrusion 304. The skin 306 can be soaked witha cleaning agent 308, of a calculated amount to clean the inside andoutside surfaces of the female port near the septum. The male luerprotrusion 304 provides a seal with the inner lumen of the female luerport. The skin 306 can be thermally bonded, glued, riveted or otherwiseattached to the cap material 305.

The inner cavity of the cap (104, 216, or 302) can include a cleaningmaterial laden with a cleaning solution. In some implementations, thecleaning material is a foam material, and the cleaning solution is aliquid that saturates the foam material. Suitable cleaning solutionsinclude isopropyl alcohol, ethyl alcohol, CHG, choloroxylenol (PCMX),providone iodine, etc. The cleaning solution can also include emollientsor other components.

In other implementations, the cleaning material and cleaning solutioncan be formed of a thixotropic substance such as a gel or foam, or of afluid with high viscosity. The thixotropic substance can include a baseviscous substance impregnated with a cleaning solution in a manner tomaintain at least a certain degree of viscosity. The thixotropicsubstance can at least partially fill the interior cavity of the cap(104, 216, or 302), and flow around the valve or port to cover a desiredsurface area when the cap (104, 216, or 302) is placed on the valve orport.

FIG. 4 shows a process flow chart 400 showing at least one featureconsistent with an implementation of the current subject matter. At 402,an opening of a cap receives a site of a medical implement having afemale port. The cap has an outer surface including a plurality ofvertical ridges on the outer surface while the opening provides accessto a single inner cavity that includes a male luer protrusion extendingup from an inner wall of the inner cavity toward the opening. The capalso includes, around a periphery of the single inner cavity, threadingincluding a friction-forming member for creating a friction-basedfitting of the cap onto the site of the medical implement. At 404, acleaning material, which includes a cleaning agent and is provided inthe single inner cavity surrounding the male luer protrusion uponreceipt of the site of the female port into the single inner cavity andthe insertion of the male luer protrusion into the septum of the femaleport, cleans at least one surface of the female port near a septum ofthe female port.

The implementations set forth in the foregoing description do notrepresent all implementations consistent with the subject matterdescribed herein. Instead, they are merely some examples consistent withaspects related to the described subject matter. Although a fewvariations have been described in detail herein, other modifications oradditions are possible. In particular, further features and/orvariations can be provided in addition to those set forth herein. Forexample, the implementations described above can be directed to variouscombinations and sub-combinations of the disclosed features and/orcombinations and sub-combinations of one or more features further tothose disclosed herein. In addition, the logic flows depicted in theaccompanying figures and/or described herein do not necessarily requirethe particular order shown, or sequential order, to achieve desirableresults. The scope of the following claims may include otherimplementations or embodiments.

The invention claimed is:
 1. A cleaning device comprising: a cap havingan opening to an interior cavity, the interior cavity defined by aninterior wall that includes a male Luer protrusion extending in thedirection of the opening from an end of the interior cavity opposite theopening; and a skin of cleaning material overlaid on at least a portionof the interior wall.
 2. The cleaning device of claim 1, furthercomprising a cleaning agent, wherein the cleaning agent impregnates thecleaning material.
 3. The cleaning device of claim 2, wherein thecleaning agent comprises at least one of isopropyl alcohol, ethylalcohol, chlorhexidine gluconate (CHG), chloroxylenol (PCMX), andpovidone iodine.
 4. The cleaning device of claim 1, wherein the cleaningmaterial is a porous material.
 5. The cleaning device of claim 1,wherein the cleaning material is a thixotropic substance.
 6. Thecleaning device of claim 1, wherein the skin of cleaning material is atleast partially secured to the interior wall by at least one of athermal bond, glue and rivet.
 7. The cleaning device of claim 1, furthercomprising a second cleaning material.
 8. The cleaning device of claim1, wherein the male Luer protrusion has a frustoconical shape thatdecreases in diameter towards the opening.
 9. The cleaning device ofclaim 1, wherein the male Luer protrusion is dimensioned for at leastpartial insertion in a lumen of a female port.
 10. The cleaning deviceof claim 9, wherein the cleaning device cleans at least a portion ofinside and at least a portion of outside surfaces of the female port.11. The cleaning device of claim 1, wherein the male Luer protrusiondoes not extend beyond the opening of the cap.
 12. The cleaning deviceof claim 1, further comprising at least one friction forming protrusionthat extends outward from a portion of the interior wall near the capopening, wherein the portion of the interior wall from which thefriction forming protrusion extends does not form part of the male Luerprotrusion.
 13. The cleaning device of claim 12, wherein the frictionforming protrusion comprises at least one thread.
 14. The cleaningdevice of claim 13, further comprising a tab that extends from a lowerterminus of each thread.
 15. The cleaning device of claim 12, whereinthe friction forming protrusion is a bendable flap.
 16. The cleaningdevice of claim 12, wherein the friction forming protrusion is made of asofter material than that used to make the interior wall.
 17. Thecleaning device of claim 1, further comprising a threaded ring that isattached to the interior wall near the opening.
 18. The cleaning deviceof claim 1, wherein the cleaning material is compressible.
 19. Thecleaning device of claim 18, wherein the interior wall is formed from arigid material.
 20. The cleaning device of claim 1, further comprising aremovable seal that completely covers the opening.